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Sascha Tuchman uses a stethoscope on a patient's back
A person changes the culture media on a cell culture plate while working in the cell culture room at the UNC Lineberger Advanced Cellular Therapeutics Facility.

UNC Lineberger’s Clinical Immunotherapy Program is conducting chimeric antigen receptor T-cell (CAR-T) clinical trials that are currently open for patient accrual. These experimental treatments involve re-engineering cells from the patient’s immune system to recognize and direct the attack against the patient’s cancer.

Pediatric Trials

Relapsed/Refractory Neuroblastoma/Relapsed/Refractory Osteosarcoma

LCCC1743-ATL A Phase I Study of Autologous Activated T-Cells Expressing a 2nd Generation GD2 Chimeric Antigen Receptor, IL-15, and iCaspase9 Safety Switch Administered To Patients with Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma

This trial combines two different ways of fighting disease: antibodies and T cells. Both antibodies and T cells have been used to treat patients with cancers, and both have shown promise, but neither alone has been sufficient to cure most patients.The primary purpose of this study is to determine whether receiving iC9.GD2.IL-15 T cells is safe and tolerable in patients with relapsed/refractory neuroblastoma or relapsed/refractory osteosarcoma. Principal Investigator: George Hucks, MD


CD30+ Lymphoma in patients undergoing autologous stem cell transplant

LCCC1524-ATL Phase I Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Prevention of Relapse of CD30+ Lymphomas after High Dose Therapy and Autologous Stem Transplantation (ATLAS)

This study is available to patients with high-risk CD30+ lymphoma who are undergoing an autologous stem cell transplant as therapy. Study participants will receive high-dose chemotherapy and autologous stem cell transplant followed by infusion of autologous CAR T-cells directed against CD30. This study is designed to evaluate the safety of this therapy. Secondary endpoints evaluate the clinical activity of this treatment. Principal Investigator: Marcie Riches, MD (No longer accruing patients)


Relapsed/Refractory CD30+ Hodgkin’s Lymphoma and CD30+ Non-Hodgkin’s Lymphoma

LCCC1532-ATL Phase Ib/II Study of the Administration of T lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Relapsed/Refractory CD30+ Hodgkin’s Lymphoma and CD30+ Non-Hodgkin’s Lymphoma

Patients must be 18 years and older. This trial studies the efficacy of CAR T cells targeting CD30 in treating patients with relapsed/refractory CD30+ Hodgkin lymphoma or non-Hodgkin lymphoma that expresses CD30. Patients who have failed treatment with autologous or allogeneic stem cell transplantation are eligible for this therapy. Principal Investigator: Anne Beaven, MD


Adult Trials

Recurrent Epithelial Ovarian Cancer

LCCC1818-ATL Phase 1 Study of Autologous Activated T-cells Targeting the B7-H3 Antigen in Subjects with Recurrent Epithelial Ovarian Cancer

The purpose of this study is to test the safety CAR.B7-H3 T cells for treating ovarian cancer. This is the first time CAR.B7-H3 cells are being tested in treatment of ovarian cancer. This study will test different doses of CAR.B7-H3 cells to see which dose is safer to be used in people. CAR.B7-H3 T cell therapy has been not approved by the Food and Drug Administration (FDA) for the treatment of epithelial ovarian cancer. Principal Investigator: Paola Gehrig, MD


Relapsed/Refractory Multiple Myeloma

LCCC1603-ATL Phase I Study of the Administration of Autologous CAR-T cells Targeting the CD138 Antigen in Patients with Relapsed/Refractory Multiple Myeloma

The primary purpose of this study is to determine whether the administration of CAR T cells targeting CD138 is safe and tolerable and to evaluate an optimal dose of cells to give as treatment. Principal Investigator: Sascha Tuchman, MD


HER2 Overexpressing Solid Tumors

CT-0508-101 Phase 1, First in Human Study of Adenovirally Transduced Autologous Macrophages Engineered to Contain an Anti-HER2 Chimeric Antigen Receptor in Subjects with HER2 Overexpressing Solid Tumors.

The purpose of this study is to see if 1. a research product, CT-0508 cells, can be made and then safely given back to patients with HER2-positive cancers and 2. the CT-0508 cells go to the sites of the cancer and cause the tumors to shrink. The CT-0508 cells are made from monocyte cells collected from the patient’s blood and transformed into macorphages, a type of immune cell that helps protect from infections and can help the immune system guard against cancer. Principal Investigator: Claire Dees, MD


CD30+ Relapsed/Refractory Hodgkin Lymphoma and CD30-expressing T cell lymphoma

LCCC1606-ATL Phase I Study of the Administration of Autologous CAR-T cells Targeting the CD30 Antigen and Expressing CCR4 in Patients with CD30+ Relapsed/Refractory Hodgkin Lymphoma and CD30-expressing T cell lymphoma

The trial evaluates the safety and tolerability of CAR T cells targeting CD30 in patients with CD30-expressing Hodgkin or T cell lymphomas, including cutaneous T cell lymphomas. The trial also evaluates whether the inclusion of CCR4 into the CAR treatment will enhance the presence of CAR T cells at tumor sites. Principal Investigator: Natalie Grover, MD


Relapsed/Refractory Acute Lymphoblastic Leukemia

LCCC1541-ATL Phase I Study of the Administration of Autologous CAR-T Cells Targeting the CD19 Antigen and Containing the Inducible Caspase9 Safety Switch in Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia

The primary purpose of this study is to determine whether receiving iC9-CAR19 cells is safe and tolerable and later to determine an optimal dose of AP1903 to be given to subjects to alleviate severe cytokine release syndrome or neurological complications from CAR T cell therapy. Principal Investigator: Matthew Foster, MD


CD30+ Lymphoma in patients undergoing autologous stem cell transplant

LCCC1524-ATL Phase I Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Prevention of Relapse of CD30+ Lymphomas after High Dose Therapy and Autologous Stem Transplantation (ATLAS)

This study is available to patients with high-risk CD30+ lymphoma who are undergoing an autologous stem cell transplant as therapy. Study participants will receive high-dose chemotherapy and autologous stem cell transplant followed by infusion of autologous CAR T-cells directed against CD30. This study is designed to evaluate the safety of this therapy. Secondary endpoints evaluate the clinical activity of this treatment. Principal Investigator: Marcie Riches, MD (No longer accruing patients)


Relapsed/Refractory Kappa+ Mantle Cell and Indolent Non-Hodgkin Lymphoma

LCCC 1811-ATL Phase 1 Study of the Administration of T lymphocytes Expressing the Kappa Chimeric Antigen Receptor (CAR) and CD28 Endodomain for Relapsed/Refractory Kappa+ Mantle Cell and Indolent Non-Hodgkin Lymphoma

This Phase 1 study will combine both T cells and antibodies in order to create a more effective treatment. The treatment tested in this study uses modified T-cells called Autologous T Lymphocyte Chimeric Antigen Receptor (ATLCAR) cells targeted against the kappa light chain antibody on cancer cells. The purpose of this study is to determine whether receiving the ATLCAR.κ.28 cells is safe and tolerable and learn more about the side effects and how effective these cells are in fighting lymphoma. Principal Investigator: Natalie Grover, MD


Relapsed/Refractory B cell Non-Hodgkin Lymphoma

LCCC1813-ATL Administration of Autologous CAR-T Cells Targeting the CD19 Antigen and Containing the Inducible Capsase 9 Safety Switch in Patients with Relapsed/refractory B-cell Non-Hodgkin Lymphoma

This Phase 1 study is the first step in determining whether giving iC9-CAR19 cells can be used to treat lymphoma and to determine if AP1903 can be used to successfully activate the safety switch in the iC9-CAR19 cells limiting the severity of cytokine release syndrome and/or neurotoxicity. Principal Investigator: Natalie Grover, MD


Relapsed/Refractory CD30+ Peripheral T Cell Lymphoma

LCCC1904-ATL Phase II Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Relapsed/Refractory CD30+ peripheral T Cell Lymphoma

This is a research study to determine the safety and tolerability of ATLCAR.CD30 for treating relapsed/refractory Peripheral T Cell Lymphoma. To prepare the body for the ATLCAR.CD30 cells, participants will complete lymphodepletion with two chemotherapy agents. Principal Investigator: Anne Beaven, MD


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